BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPT 12/14 SIZE 1 COCR EXT

    MDR report key: 19772067 · Received July 18, 2024

    Report

    Report Number
    0002648920-2024-00233
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 27, 2024
    Report Date
    October 29, 2024
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    JDI
    UDI-DI
    00889024145764
    PMA / PMN Number
    K191735
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: 802202802 ITEM NAME ZB 12/14 COCR HD 28MM X +0 LOT # 3190326 EP-200150 ITEM NAME ACT ARTIC E1 HIP BRG 28X44MM LOT # 66246658 110024464 ITEM NAME G7 DUAL MOBILITY LINER 44MM F LOT # 66310981. G2: FOREIGN: AUSTRALIA. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT¿S LOCATION IS NOT KNOWN; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED UPDATED: B4, G3, G6, H2, H6 STEM, H11. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. RADIOGRAPHS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: LEFT TOTAL HIP ARTHROPLASTY WITH ASSOCIATED SUPERIOR AND POSTERIOR DISLOCATION OF THE FEMORAL HEAD AND EVENTUAL WITHDRAWAL OF THE FEMORAL COMPONENT WITH ASSOCIATED COMPONENT ROTATION. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THIS COMPLAINT WAS CONFIRMED BASED ON THE PROVIDED MMI REPORT CONFIRMING THE REPORTED EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE 2 MONTHS AND 13 DAYS POST IMPLANTATION DUE TO DISLOCATION. THE STAFF IN EMERGENCY DEPARTMENT ATTEMPTED CLOSED REDUCTION UNSUCCESSFULLY. THIS RESULTED IN BOTH THE HEAD DISSOCIATING FROM THE DM BEARING AND THE CPT STEM MIGRATING CRANIALLY OUT OF THE CEMENT MANTLE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE PRIOR EVENT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555457 CPT 12/14 SIZE 1 COCR EXT PROSTHETIC, HIP JDI ZIMMER MANUFACTURING B.V. N/A 66481402 00889024145764

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention| H PLEASE SEE H11.